BEUDAMED
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    InkSpace Imaging Pediatric Body Array

    FDA 510(k)
    FDA Class 2 ·Radiology

    PACIFIC HEMOSTASIS REFERENCE EMULSION

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ZEUS ELISA BORRELIA VLSE-1/PEPC10 IGG/IGM TEST SYSTEM

    FDA 510(k)
    FDA Class 2 ·Microbiology

    PROXIMATE LINEAR CUTTER

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·October 30, 2014

    PINNACLE MTL INS NEUT36IDX54OD

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC. 1818910·Product code KWA·August 12, 2011

    TRI TS BASEPLATE SIZE 4

    FDA Adverse Event
    Malfunction ·STRYKER ORTHOPAEDICS-MAHWAH·Product code JWH·July 9, 2013

    18L6 HD transducer on the ACUSON S Family ultrasound systems with software versions VD10A or VD10C; Model numbers: 18L6 HD transducer  10041227 & 10789400 S1000  10441701 S2000  10041461 S2000 (Refurb) - 10440017 S3000  10441730 Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc.·May 3, 2017

    DRX Revolution Mobile X-Ray System

    FDA Enforcement
    Class II ·Ongoing·Carestream Health, Inc.·December 13, 2023